Post-Authorization Safety Program—Validation of the Clinical Practice Research Datalink for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38910
• EU PAS number:
  EUPAS5529
• Study ID:
  38910
• Official title and acronym:
  Post-Authorization Safety Program—Validation of the Clinical Practice Research Datalink for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Mirabegron is a first in class therapeutic agent, with a mechanism of action distinct from that of antimuscarinic agents indicated for the treatment of overactive bladder (OAB). This is a retrospective cohort study of new users of individual antimuscarinic drugs: oxybutynin, tolterodine, darifenacin, solifenacin, trospium, and fesoterodine. The objectives are: to describe drug-use patterns, to calculate background rates of cardiovascular (CV) and cancer outcomes among antimuscarinic drug users and to validate outcome-specific case-identification algorithms based on electronic diagnosis codes in the Clinical Practice Research Datalink (CPRD) in the United Kingdom. Upon validation these algorithms will be used to evaluate CV and cancer risk associated with mirabegron as part of the required post-approval safety program to be implemented in the US and the EU.The study period is January 2004 through December 2012. The study will calculate incidence rates of the following endpoints: - CV: including acute myocardial infarction, stroke, all-cause mortality, CV mortality and a composite endpoint.- Neoplasm endpoint: including the 10 most commonly occurring in the general population.The data retrieved from primary care data, which contains prescriptions issued by the general practitioners (GP) and medical information recorded by GPs as part of their routine clinical practice, will be compared with information from other sources. The data are linkable, at least for a large subset of patients, with other health care data sets (e.g., hospitalization records, national mortality data, census data, cancer registry).
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Planned: 05/04/2013

Actual: 12/06/2013

Study start date

Planned: 15/03/2014

Actual: 31/03/2014

Data analysis start date

Planned: 01/07/2014

Actual: 27/08/2014

Date of interim report, if expected

Actual: 31/03/2015

Date of final study report

Planned: 28/08/2015

Actual: 28/08/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Study protocol

Initial protocol

178-CL-116 Validation Protocol_sigs-redacted

Updated protocol

178-cl-116-clp-02-reissue-en-v3dot2_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)